NCT05306145

Comparison of H-FIRE and TURP in Treating Benign Prostatic Hyperplasia

A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High Freqnence Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This trial is comparing the effects and safety in treating men with benign prostatic hyperplasia between high freqnence irreversible electroporation and trans urethral resection prostate.

Detailed description

A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High-Frequency Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia One hundred and seventy-six patients with benign prostatic hyperplasia will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-freqnence irreversible electroporation; arm 2, transurethral resection prostate. The primary outcome is the change in maximum urinary flow rate and urinary symptoms by questionnaire of International Prostate Symptom Score at 3 months after surgical treatment.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	High freqnence Irreversible electroporation	High freqnence Irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with benign prostatic hyperplasia
PROCEDURE	Trans Urethral Resection Prostate	Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic

Timeline

• Start date: 2022-06-30
• Primary completion: 2026-01-01
• Completion: 2026-04-01
• First posted: 2022-03-31
• Last updated: 2024-11-19

Locations

1 site across 1 country: China